Grafton DMB Matrix bone graft recalled for potential outer pouch defects
Medtronic is recalling 377 units of Grafton DMB Matrix demineralized bone matrix devices due to potential defects in the outer Tyvek pouch from a missed manufacturing inspection step. No patient injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a precautionary Class II recall based on a manufacturing process deviation with no reported adverse events or injuries. The hazard is theoretical—potential non-conformances in outer packaging—rather than confirmed device defects or patient harm.
Plain-English summary
Medtronic Sofamor Danek USA Inc has recalled 377 units of Grafton DMB Matrix demineralized bone matrix (Model Numbers T42200 and T42210) due to potential defects in the outer Tyvek pouch packaging. Specific serial numbers are affected.
The recall was initiated because a required inspection step for the outer Tyvek pouch may not have been performed according to specifications during manufacturing. As a result, some batches may have been released with non-conformances in the outer pouch that were not detected.
The affected devices were distributed in the United States, Colombia, South Korea, New Zealand, India, and Taiwan. A complete list of affected serial numbers is available in the FDA recall notification Z-0163-2024.
No adverse events or patient injuries have been reported. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- packaging-defect
- quality-control-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) T42200: GTIN 00643169123052
- Serial Numbers: A59254-013
- A57871-018
- A59117-013
- A59254-018
- A59264-016
- A58526-014
- A58526-015
- A58526-016
- A58864-018
- A58082-016
- A58983-011
- A58983-012
- A59320-013
- A59320-016
- A57043-011
- A58831-018
- A59307-012
- A59320-019
- A58831-019
Distribution
Distribution scope not specified by the agency.
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